Our medical device validation services ensure that products meet all required standards for safety and performance. We provide comprehensive validation processes, including design, process, sterilization and final product, using industry-leading methodologies and regulatory guidelines.

Equipment qualifications
We prioritize the stringent qualification of our equipment to ensure optimal performance and reliability throughout our manufacturing processes. Including design, installation, operation and performance qualifications.

Production line validation
Our comprehensive validation process spans various aspects to guarantee the consistency, safety, and efficacy of our entire range of medical devices.

High volume production
Rigorous validation of our production processes to ensure scalability and maintain product quality at high volumes, meeting customer demands while adhering to strict regulatory standards.

ETO sterilization validation
Ensuring efficiency of our Ethylene Oxide (ETO) sterilization, we validate the process in compliance with ISO 11135 and ISO 10993 standards, safeguarding device sterility and safety throughout their lifecycle.

Accelerated Aging Studies
We predict product shelf-life by subjecting them to elevated temperature and humidity in our climate chamber, and evaluating their performance and durability through the study.

Real-Time Aging Studies
Monitoring of products under normal storage conditions to assess stability and performance in real time.

Clinical studies
Through collaboration with healthcare professionals and institutions, we conduct rigorous trials to validate safety, efficacy, and performance in real-world settings, ensuring regulatory compliance and delivering tangible benefits to patients and healthcare providers.